Episode 52- Special Edition: The Race Towards A Vaccine

DISCLAIMER: I am not a doctor or a healthcare practitioner, nor do I have a master's or a PhD. I am not a native German speaker either- I only know German as a foreign language, one I learned using whatever resources I could get a hand on. If my translation conflicts with that of anyone belonging to any of the groups mentioned above, please refer to theirs instead of mine. Needless to say, if an official translation, done by a scientific translator comes out, then refer to that instead of this one. I am simply a medical student who admires the work of Dr. Drosten and colleagues, and I would like to provide unofficial translations of the podcasts so that they may be helpful to those who do not speak German.For corrections, please reach out to me on Reddit and send advice in. I apologize in advance for any errors I have made. There are some footnotes at the bottom of this translation.

Original audio: https://mediandr-a.akamaihd.net/download/podcasts/podcast4684/AU-20200806-1358-4600.mp3
Original transcript: https://www.ndr.de/nachrichten/info/coronaskript218.pdf

ANNOUNCER: NDR Info. The Coronavirus update.

MARTINI: Welcome to the Coronavirus Update. Christian Drosten is still on summer break so we have gathered this group of experts from different fields of specialty in order to talk to you about the Coronavirus.  On this episode: the race towards a vaccine, a topic that has been talked about quite a lot.

VARIOUS EXCERPTS FROM THE PODCAST: “Everything is going to plan and now comes the news that doses of the vaccine are already being bottled…”
“It is true that we cannot cut corners when it comes to safety. Both because of concerns of safety and effectivity.”
“The conferences are of course a sign that things are headed in the right direction but it is of course very, very important, from a global perspective, to ensure that the vaccines reach the entire world.”
“The reason for the fact that countries have invested so much is to secure a supply of vaccines for themselves, and this is not an optimal solution to the current issue of distribution.”

MARTINI: (continued). And this is what we want to do in the course of this hour. My name is Anja Martini, scientific editor at NDR Info. These are my guests: Professor Dr. Marylyn Addo, leader of the Department of Infectiology at the University Medical Center Hamburg-Eppendorf. Welcome, Dr. Addo!

ADDO: Hello!

MARTINI: She says that never has the pace of vaccine development been so rapid as nowadays. Aside from her, connected to us via the app, we have Professor Dr. Alena Buyx, Professor of Medical Ethics at the Technical University of Munich. Hello, Dr. Buyx.

BUYX: Hello.

MARTINI: She says that we need a model for the just distribution of a possible vaccine. We also have Professor Dr. Hans-Georg Eichler, who is a professor of clinical pharmacology at the Medical University of Vienna, and a leading doctor at the European Medicines Agency, whose headquarters are in Amsterdam. Hello Dr. Eichler.

EICHLER: Hello.

MARTINI: You are also connected to us via the app, and you say that if there will be a vaccine, the utility of the vaccine will outweigh the risks. Also connected via the app: Professor Wolfgang Greiner. He is a Professor of Health Economics and Health Management at Bielefeld University. Hello.

GREINER: Hello, Ms. Martini.

MARTINI: Professor Greiner says that if there is to be a vaccine, no price would be too high to pay, in order to limit the social and economic damage. But the price of such a vaccine would also have to be socially justifiable. These are the people we have here today. And I am glad that all of you are here and are willing to take a brief look at the situation. But let’s have a recap about events leading up to today, August 6, 2020. 	The Robert Koch Institute has released new statistics and advises caution because the number of new infections has gone up again. Dr. Addo, do you agree with them? Many have taken advantage of their freedom and have now gone on holiday. What do you say, was this the right thing to do, from your point of view, namely, the point of view of an infectious disease specialist?

ADDO: To go on vacation? I believe that’s okay. I also agree with the warning to be cautious because we are in the middle of a pandemic. If this is now a second wave, a mild second wave, or whatever you want to call it, that remains to be seen. But we must also proceed knowing that this autumn, when we open schools again, those returning from vacation will come back, and we will have relaxed restrictions. But we also expect that the numbers will rise a little in the autumn? We must—the demonstrators say the—we must still keep these measures because…We are simply not finished with this topic.

MARTINI: Dr. Eichler, in your opinion, are the concerns of the Robert Koch Institute justified?

EICHLER: Yes, absolutely. But I also agree that this isn’t completely surprising. And from our point of view, this is a situation that won’t go away on its own. We can only control this situation in a reasonably short time if we have an effective vaccine.

MARTINI: Dr. Buyx, Dr. Addo has already mentioned the demonstration. Are we losing our solidarity for each other? What do you believe is happening?

BUYX: I would not go that far in any case. I find it very important to note that the vast majority of people are careful and support the measures that are still being taken. The news reports distort this perception somewhat because we naturally tend to pay more attention to those protesting against these measures. I believe that overall, there is as much solidarity now as there was before. But solidarity has its limits, which one has to be mindful of. We have seen a relatively normal development, in which people, who have some freedom back, are using it and thus the infections go up. Regarding autumn and winter, I believe that we must remember to be careful again. Nobody wants a second, wide-reaching second lockdown. And at the same time I believe it is very important to understand what exactly brings people to reject all of this. I believe we must really try, through suitable communication, to remind everyone that we are all sitting in the same boat.

MARTINI: Professor Greiner: we have adopted the so-called AHA rules well, namely, to keep your distance, to be hygienic and to wear masks(1). From the perspective of a health economist, is this appropriate?

GREINER: At their core, these rules are a health economists dream, because they cost very little and have such great effects. You can’t think of anything better than this. Rather, the problem lies in psychology, which is very important in terms of the economy. For instance, everyone knows that the use of masks lies primarily in the protection of others. That is widely recognized, I believe. But such an incentive is still not as long-lasting as to know that you’re protecting your own self. That has effects on how we as a society move forward. For instance, belief that society is recovering, which is very vulnerable if we see that the number of infections is rising again?

MARTINI: What should you probably do in the autumn? Dr. Eichler has explained: the question is clearly, “when will we have a vaccine that can help us go back to normal?” Dr. Addo, how often has this question been asked of you in the last six months?

ADDO: Too many times to count.

MARTINI:  Every day?

ADDO: Yes, every day. I ask myself this too, when is the vaccine coming? But this isn’t an easy question to answer now. There is no good answer to this. If we try to imagine where we are, we find ourselves on this journey—this is very remarkable—on this path that we have started off on in January. We learned the sequence of the virus in January. And the thing is, once the new pathogen broke out, someone was able to be given a vaccine as part of a clinical study within three months. This has never happened before. That is dramatic and also very impressive. Of course, these possible vaccines are in different phases of development. We already have the first Phase 3 studies, six of them, that are now being conducted in Brazil and South Africa, and it’s only August. That is very dramatic. So we must expect that these signs, these vaccines…The first studies are primarily concerned with the question: is the vaccine safe? Are there side effects? What is the optimal dose? The Phase 3 studies test whether the vaccine really does protect people from infection—we are waiting for the first results in the coming months. This is very exciting. If results are favorable, there certainly will be an emergency approval for distribution. Dr. Eichler can certainly talk about this better than I can. But these are exciting times that lie in front of us.

MARTINI: You are also in a research team for developing vaccines. And you also have a team working in Munich, in Marburg, in Hamburg, within the framework of the German Center for Infection Research. There is research there as well towards a vaccine. I believe that there are three vaccine projects in total throughout all of Germany. How far along are you with this?

ADDO: Compared to studies being performed elsewhere in the world and even within Germany, we are very much behind. Our Phase 1 study is to begin in September. We are working here with a viral vector that we have already tested for the MERS (Middle East Respiratory Syndrome) virus, which is another coronavirus. We have already published data this year about tests performed on people in Hamburg in which the safety of such a vaccine was tested. This method may be able to be used in a Covid-19 vaccine. Hence the Phase 1 trials, which begin in September. And then afterwards, Phases 2 and 3. Phase 2 shall begin this year, and other studies will start Phase 3 trials in September.

MARTINI: This means that your team is going in the right direction, according to you?

ADDO: Yes. Everything is going to plan, and today a piece of news came up, saying that some vaccine doses have already been bottled. The vaccine vials are already ready.

MARTINI: So, we’re on the right track. There are at least 160 vaccine projects worldwide, all geared towards finding a vaccine against the coronavirus. Twenty-three of them are already in clinical trials, I believe. Dr. Eichler, perhaps you have a good view of all this, seeing as you work at the EMA. How much pressure is there on these individual research institutes, research teams, pharmacological industries and so on, to find a vaccine?

EICHLER: There is a lot of pressure, of course. We have already mentioned this, the rising numbers, the economic consequences and the fact that we might not come out of this scenario with a vaccine—there is a lot of pressure because of this. You shouldn’t draw conclusions yet, though. And let me come back to what Dr. Addo said: I agree with every single word that you said, and I can’t really add anything more. But I would like to clarify a particular phrase. You spoke of an “emergency approval”. I know where this is coming from. Our colleagues in the USA have a so-called “Emergency Use Authorization”(2). I can translate that phrase into German and see where you get the phrase “emergency approval”. The danger of this phrase is that one might think that we would be cutting corners here and there, doing things “quick and dirty” (3).That is not the case at all. Dr. Addo has said it herself: we go through these three phases. Whatever you call them is irrelevant. The most important thing is that we don’t take shortcuts. Regarding evidence of safety and effectiveness, we insist on what is called the protective effect, namely, that the vaccine can be shown to protect against infections in field trials. A classic shortcut would be to say that we can be satisfied if the process is made faster by simply looking for an immune response—which fits quite well in some laboratory scenarios. This isn’t a big problem. If this sort of method is approved, then we can allow it. But (regarding vaccines), this is not so. We insist that we must demonstrate the protective effects against a virus which has not been incapacitated. So yes—an emergency approval, in the sense that we must speed things up. But not because we are reducing our standards.

MARTINI: This means that we must insist on maintaining the quality of the tests. But the pressure on the system is still there. Professor Greiner, when you look at this pressure, you can see that this is because we must quickly find a vaccine. But there is also the pressure of the fact that lots of money has been poured into vaccine development. How do you feel about this? Is it right for so much money to be put into the market for the development of medical supplies and vaccines?

GREINER: I believe that money is, at the moment, the least of our concerns. We have a lot of money available. You can see this in many other aspects of society, that money has been mobilized. Of course, for the chance to obtain a vaccine, no price is too high. There is, however, the question of who will finance this. Does the money come from the State? And which specific areas of research should be subsidized by the state? Or does the money come from private initiatives because of the huge incentives of a vaccine—everyone will be vaccinated and so on…Whether this really is the situation is another question. In any case, they’d want to at least provide such a vaccine. And regarding prices, there are certain things that indicate that healthcare systems are willing to pay very high prices, which would be very attractive for private investors. Nevertheless, a lot is being done on the part of governments at the moment, not Germany’s. I have my doubts about whether the present state of things is the best way to go, because actually…Well, government money should be invested in research if it is basic science research. There are many efforts in this regard, including what Dr. Addo and her colleagues are doing. This is typically something that should be financed by the state. Also, in some cases, there might not be anyone who can cope with the uncertainty of the fact that not all 160 candidates, those you have mentioned, will succeed and be able to show results. If nobody is willing to handle this uncertainty, someone can come along and say, “Okay, we will partly fund the research so that we can allay some of your worries about this uncertainty.” I don’t see this unconditionally. In the end though, the reason that states invest so much into research is to secure a vaccine for themselves. The reason for the fact that countries have invested so much is to secure a supply of vaccines for themselves, and this is not an optimal solution to the current issue of distribution.

MARTINI: Let’s return to that again. Dr. Buyx, when you look at this situation as a medical ethicist, do believe that it is right that money is poured into the development of medical supplies, thus piling on the pressure, so to say?

BUYX: From an ethical and sociological perspective, we simply must have a vaccine, as Mr. Eichler has put it very clearly. Or perhaps we will have multiple vaccines to save us from this pandemic. Because of safety measures, we have massive costs in many areas of society. A vaccine is therefore the “exit scenario”. How exactly to best handle financing—this is something that’s beyond my capacity to answer. But I believe that it makes sense for governments to get involved, especially considering that we will probably face shortages in the beginning. To leave this up to private entities is, I believe, very problematic. When we are dealing with scarce resources, they must be distributed justly. And this would be of utmost importance in Germany, where we are used to having vaccination schemes anyway, so if we were to think very carefully over the issues of distribution and state legitimacy—how, then, would we do this?

MARTINI: What would such a distribution look like from your perspective?

BUYX: First off, we have the advantage of being able to think of this now. I find it fantastic—we must emphasize this—from an ethical perspective, it’s really crazy how much activity is going on and how far we have come. We still have the opportunity to ask these questions. Secondly: this scarcity will only happen at the start and won’t last. As long as it is present, however, we cannot give everybody what they need. That means that we have a real problem with just distribution. We need priorities. And this is being intensively discussed at the moment. There are different models, even one for the WHO for instance depicting the whole world. In different countries, including us in Germany, we have for instance the Standing Committee on Vaccination (SCV), who are thinking about this. There are many such discussions, albeit preliminary ones, because there are many suggested criteria for “just distribution”, such as minimizing damage, reducing mortality rate, reducing the spread of the disease, saving lives, doing good for society, but keeping the system running. We need, most especially for instance the healthcare system, but also solidarity, so that the weak are protected, in whom the effects of Covid-19 are especially strong, as well as those with special risk factors. And finally—many are surprised by this, but this is also an important criteria for justice—we have effectiveness, namely, whether the vaccine really works. There will be vaccines that work differently in different populations and depending on how they are transported…what do I know, Dr. Addo knows much better than I do. And based on these criteria, priorities can be worked out. There is a vague sense of unity, but there is a lot of debate over the details.

MARTINI: Dr. Addo, what would a just distribution of vaccines look like, from a medical perspective?

ADDO: Dr. Buyx has said that this is a complex topic and thus there are no simple answers. And I must agree, it’s amazing, how present ethical questions are in these discussions even though we don’t yet have a vaccine. This is very dramatic. And there was a conference—two, in fact, for which money was collected from all over the world. People have learned from other scenarios. There have been disagreements over vaccines, for instance in the case of flu vaccines. Knowing that such conversations, interdisciplinary ones, are being held, is very impressive. From my humble medical perspective, I would say that when I think of the most affected ones, when I think locally of the University Medical Center Hamburg-Eppendorf, where 170 patients were in stationary care, I believe that we should begin with patients, with risk groups, that are most at risk of dying, for instance. Of course, healthcare workers, frontliners, highly exposed people should also be included. But a good, just concept should be developed on the basis of the arguments that Dr. Buyx has mentioned.

MARTINI: Professor Greiner, is there a chance of a just distribution? And if so, how would it look like?

GREINER: Basically, it would be something similar to what we have just heard. We need a model with which we can draw conclusions about which effects the vaccine may have on certain groups if we don’t vaccinate others. Scarcity means that we must make a decision. Dr. Buyx has made this completely clear. This is very unpleasant. In terms of healthcare we must really…when we can, avoid this. Eventually, if we don’t get to a point where production can make these considerations of scarcity irrelevant, we will hav to make such hard decisions. And such a model will continue to be improved on, because it will encounter new situations. I have recently read that it may be that children would be the last ot be vaccinated. I hope that this won’t happen. But because of considerations of how infections work in reality, which are fed into such a model, as well as how infections will continue to develop in the future, if certain groups are vaccinated—such a thing was decided on. If there eventually are enough vaccines, we will not have these limits any more. But for the time being we need them. And thus it is very hard to say what a just distribution would look like. What we have just discussed were criteria. And the economists would naturally ask: what do we want? We want as few infections as possible. We want as few complications as possible and we want as few hospitalizations as possible and a high quality of life for patients and so we work things out. This could mean however that certain groups may eventually be left out. And then the ethicists would come and say, “We don’t approve of this at all. For the very old or other such people we must have other regulations.” These criteria precisely—it is very interesting to discuss this. In all other areas, I believe, we still don’t know everything about the illness. And we don’t know at all which medicine will have which effect on which patient groups—assuming, that is, that there are medicines at all.

MARTINI: Where, Dr. Buyx, would be the proper place to discuss this?

BUYX: I would like to say something else first.

MARTINI: Please do.

BUYX: Because I believe this is interesting for everyone listening now. What Dr. Addo said is interesting. What Professor Greiner said, too. There is already a consensus on priority. Healthcare workers are at the top of the list for everyone currently working on this. All the criteria we have spoken about point in this direction. The uncertainly lies in if and where, for instance, certain at-risk groups stand, as well as certain others who have so-called “system relevance”, for instance teachers, daycare workers and so on. There are a lot of discussions on how exactly to give priority, but a consensus seems to be emerging. There is also the devil in the details: which healthcare workers are included, exactly? The consensus seems to be that healthcare workers are to be first in line. Where this is discussed: It is already being discussed in the SCV, the competence network…

MARTINI: The Standing Committee on Vaccination.

BUYX: Sorry. From the Standing Committee on Vaccination, from the competence network, an association of many colleagues working in public health. I believe it wouldn’t hurt to establish another such commission, one that would represent a wide, interdisciplinary range of competencies, in order to establish a transparent communication strategy. From an ethical perspective, we have a very interesting situation. On the one hand we speak of scarcity and say that we may have too few vaccines. And on the other hand we have this problem, that certain groups in our society are saying that they want none of this, that they don’t want to be vaccinated. And I believe it is pretty important that we proceed properly with the implementation of vaccines. And I can imagine that it would make sense to have a committee to deal with the issue of prioritization. And another one to deal with communication strategies. These should be ethically set up, should be wide-reaching in society and well-polished, and should listen to many viewpoints, be inclusive and so on.
MARTINI: Dr. Eichler, you are responsible for the Europe-wide distribution of medicine and vaccines. Can these concerns or possibilities be taken into account in the approval process? What are the chances that these will have an effect on the just distribution of such a vaccine?

EICHLER: Allow me to clear up something before I answer. It was said that there would be a bottleneck. Will we have enough vaccines later on? The answer is most likely yes. It is a question of when. It could be that, if we’re lucky, it will only be a short time before so much is produced that there is enough for everyone. We are talking about a short period of time. This is the first point. The second is about ethics. Is it a matter of regulations? No. We do not regulate the practice of medicine. We do not regulate public health, we regulate products. What we can contribute to this debate—and this is already happening—is—as I believe Dr. Buyx has already said—the questions of effectiveness and tolerability. For most medicines…in fact, I can’t think of any of them for which this isn’t the case. And so it is for vaccines, too. The benefit to risk ratio is not equal between groups. For instance the young versus the elderly. Old people are risk groups, we know that. We also know that the elderly have a weaker immune system. We know that the elderly respond differently to vaccines compared to young people. That means that it is possible—not only possible but likely, even, that a hypothetical medicine may have very good protective effects in young people, but not so much in the elderly, and in some groups of people none at all. We can work this out from studies. It is important that we make this information available so that other people can take part in this debate, which is also an ethical debate and an economic debate. We must not ignore these scientific aspects. They must be the basis on which ethical questions are asked.

MARTINI: Ethical—and as you have said, economic questions. The ethical debates are ongoing. So are the economic ones, Professor Greiner, because many governments are investing money in different pharmaceutical companies for no other purpose than to secure some vaccine doses for themselves. Does this mean the vaccines are already de facto distributed?

GREINER: I hope not. I hope that the answer to your question isn’t yes. But I fear it might be so. What I see now is that, regarding the social and medical challenges we have to face in this pandemic, the situation is as you have described it—namely, that some states, depending on their ability to pay, have already secured some of the supply for themselves. And this would leave out developing and emerging countries and so on, or they may only be able to get leftovers. In the pandemic, everything is connected, and one’s actions can affect another’s actions which affects their own again and so on. It will probably not come to pass that, if a vaccine exists, or has existed for two or three years, we will all be protected against the virus. Rather, we will continue to have certain outbreaks because we are an open country and we have an open economy. It doesn’t make sense to proceed in this manner. We must also think that as a net exporter, it is in our best interest to ensure that other countries continue to function, or at least in the future will function well. In countries such as the USA which is fighting among itself and is experiencing high unemployment and low income and so on, it would be very difficult to do business there. This may sound cold, but I am saying it to show that it doesn’t make sense to hoard vaccines even though they’re not here yet, through preliminary contracts. Rather, it is more important to cooperate internationally and work together because no one person can sign contracts with all 160 candidates. Maybe we’ve gone a little overboard. It would be better to agree to support a part of the production or a part of the international market. I believe that the USA isn’t on board with this. But the EU can, within its borders, work things out with other countries responsible for vaccine development and think about which criteria to go about international distribution with. We have already spoken about how vaccines are to be distributed amongst individual patients. I hope so.

MARTINI: Maybe the WHO?

GREINER: Yes, the WHO would be the first choice. There are already a few projects geared towards these issues. I don’t believe they’re very strong yet. This is why, from a purely political point of view, I would think that other institutions which have more power, such as the UN or the EU, have better chances. There must be more than just conferences, where only money is pooled together for research. We must think about which criteria we really want to use when distributing products later. I am not naïve, nor am I 100% sure about these matters. Each country is entitled to the vaccines to a certain degree proportionate to its population—but what about in proportion to demographics? Considering this, we must work out something of a plan of how to justly distribute the vaccines between countries.

MARTINI: If we look at the situation, Dr. Buyx, is it too late? Will poorer countries obtain the vaccines more slowly, or perhaps later than others?

BUYX: Hm, I really can’t give you an answer. I hope not. But I have to agree with Professor Greiner, things are proceeding in that direction…this is really a struggle. It would certainly be best if, instead of a few countries taking part in this struggle and then driving up prices, a “wide front” is built. The WHO is trying, among other things, to appeal to global solidarity, in order to promote for instance the sharing of information, the sharing of intellectual property. However, this is an initiative which relatively few Western countries are occupied with. The conferences are of course a step in the right direction. But it is of course very, very important, from a global perspective, to ensure that the vaccines reach the entire world. This is because—this should be emphasized—if the vaccine hasn’t reached the entire world, we will not be rid of the pandemic. It will come back again because we live and work in so globalized a manner. I believe that it is therefore somewhat wrong to say that we will sort the problem out in Europe and then all will be well. Not only because that is very cold-hearted and we have a duty to respect human rights everywhere, but also because this is not in our best interest. This is why I really hope that regarding the efforts going on throughout the world, even in poorer regions, we will exert less of an economic pull and less power, so that we, together, can bring vaccines to the world.

MARTINI: Dr. Addo, listen to this—1.7 million in this company, 1.8 million there—it seems as if America is going shopping. As a researcher, as a scientist, is this difficult to listen to? Or is it best to put that aside and say, “I don’t want to hear it—I would rather go about in my laboratory and work in peace with my team.”

ADDO: In this situation there is an insane amount of pressure. There exist many influences. I, as a clinician, have different opinions. It is a priority for me to focus on the team. They have been in overdrive since January and will probably be so for another year. That is why we’re concentrating on our work and taking things one step at a time. As mentioned before, we aren’t taking shortcuts. We are focusing on this, focusing on moving forward. Naturally, we are right in the middle of general social discussions and we’re watching them closely. I would say I am far removed from this discussion about investing. I have however seen some developments which surprised me. This is of course a special situation. We don’t have any blueprints, so we just did things however. That is why I am, perhaps naively, surprised to see that the topic of just distribution has become political and is being discussed in the EU. Whether we actually act on this and avoid a situation where there are leftover stocks that don’t end up reaching India or Africa—this remains to be seen. There is also this fact—many of the countries with the highest numbers of infections are also conducting vaccine studies. One gets the impression that these vaccines aren’t themes that you can just handwave away. In South Africa, in Bangladesh and so on, there are studies. At the moment, within the framework of studies, the vaccines will have to be made available. Of course, the companies will not just pull the plug and say “So, we’ve eradicated the disease in Brazil and the vaccine will no longer be made available.” These are naïve considerations. But it is very important that we, as a world community, focus on ensuring that the world can have a share of the vaccines.

MARTINI: Let’s go back to the topic of research, we are assuming that they can handle it and that there will someday be a vaccine. How many people do you say must allow themselves to be vaccinated? Current studies seem to say that this number is lower than previously thought. We thought that 71% of people should be vaccinated, and now this figure has shrunk to only around 60 or 61%. What does it mean from a medical perspective if even more people decided not to be vaccinated?

ADDO: This is no easy question. It is very early. To start with, we don’t really know anything about natural infections or natural immunity. How long do they stick around for? We don’t know exactly what sort of vaccine—vaccines, there will probably be a number of them—what sort of vaccines will come out. Will it be something similar to how the flu vaccine works? I am not implying that we will have to make a new vaccine every year. That didn’t happen with SARS. But rather, that the vaccine may not work in 99% percent of the people who receive it, but rather in around 70%. These are all numbers that play a role. For me it is important to say that among the general public, the debate goes like this: we will wait for the vaccine. First off, as we have said many times in this discussion, there will probably be more than one vaccine. But a vaccine will be a step, a very important step at that, in our way out of this crisis. This exit will surely take years. Not only do we have to worry about not being able to distribute the vaccines, but we also have to worry about those who won’t get themselves vaccinated, who won’t allow themselves to be vaccinated. We see this as well in the flu vaccine, which is not taken by as many people as it could be. Thus it is definitely not easy to answer questions about herd immunity, about the 70%,, because all of this is built on thin ice, as long as we have so many open questions. I believe that if we can  increase immunity and limit the spread of infection or something like that, that would already be something good. Of course, the studies in the second half of the year will hopefully be able to do this. Next year, in the first, second quarter, we will hopefully get some data about how protective the vaccine really is. And then we can start to calculate how many people should be vaccinated. Who we should vaccinate. There are many things still left unanswered.

MARTINI: Dr. Eichler, there is an accusation that since everything must go quickly with the vaccine—you have mentioned this at the beginning—that the quality of testing of the vaccine might suffer as a result. In your opinion, is it possible for a vaccine to be developed quickly and safely?

EICHLER: We think so. I cannot of course speak of results yet. Nobody can. In English people say “cut and corny”, meaning “quickly and roughly.” That is not the plan. We try to do things quickly and well. How do we do this, you might ask. On the one side, we can all work more quickly. Everyone has reserves. This is not surprising. There is something else, another dimension, where we can better ourselves though. The development of a vaccine or any sort of medicine is a very complex process comprised of so many different procedures. I can do things serially, one after the other—first comes A, then B, then C and so on. I start off with micro-level studies, then I move on to animal subjects, then I move on to the so-called Phase 1 clinical trials, then Phases 2 and 3. In the meantime we have so-called “white spaces”, namely, pauses. These can last for up to half a year in the normal course of development, where nothing is happening. During this time the data is tested, then we consider: what now? Where do we go from here? Where will we do the tests and so on? These white spaces and serial workflow can be, under pressure (which is the case now) be improved by performing procedures in parallel. This is happening now. While we are doing the Phase 1 studies for instance, we start making the infrastructure for the Phase 2 studies so that the day we have results, we can start with Phase 2. The same goes for other studies. For instance (this happens rarely under normal circumstances), some animal studies that aren’t absolutely necessary to ensure the safety of test subjects are conducted in parallel with the first clinical studies. In this way we can save time without compromising quality. This can’t be done with everything. But it can be done under the sort of circumstances we are in. This is extremely resource intensive, this makes research and development inefficient. Imagine having to do this for all the ongoing vaccine projects. You would have to invest in the next phase even if you don’t know if the first will be successful. The cost of development will of course rise because we will have to expect a lot of financial inefficiency in order to go faster. And this is an important point. There does not have to be a balancing act between speed and quality. Both are important. It is resource intensive.

MARTINI: If this is done, namely, if a vaccine is found and everything was done quickly and effectively, should the price be lowered, in your opinion, Professor Greiner?

GREINER: I’m not so sure.

MARTINI: I see.

GREINER: The question of pricing is something else entirely. It will be asked again when we know how many candidates for vaccination there really are. Or if there’s something like a competition. Maybe a monopoly would have different effects on prices compared to if we have multiple vaccines of equal quality. At the moment, determining a price is so difficult that virtually any price can be set. You can see in terms of economics how the damage due to the pandemic is so great that you would pay absurdly high prices for vaccines that really work. We of course don’t want this. We need other mechanisms to prevent this. Most healthcare systems are prepared for this even though we normally don’t assume that vaccines are so severely needed as in these times. Also this is a rather new situation. We must look at how prices were determined before in order to orient ourselves. All in all though, there is much willingness to pay. I would also like to clear something up about the vaccine quotas we have discussed. I believe that we have something similar to what is called a “penguin effect” in economics. This means that…Penguins only jump into the water after another has gone before them in order to see if there are predators inside. Similarly, in uncertain times a few people must be willing to act first. This means that if people are less willing to get vaccinated, I would chalk it up to the fact that people would rather wait and see. Precisely because phrases such as “emergency approval” and so on are making their rounds while people aren’t sure whether the vaccine is really as safe as it is for the flu vaccine. I believe that this unwillingness will disappear after a year when people see that no, others aren’t undergoing side effects, and might just have some advantages. There would clearly be fewer infections, and thus, people would be more ready to get vaccinated. You have to go through this phase. That is I believe a bit of the price we have to pay to go faster while, as Dr. Eichler has said, not compromising quality as much as possible.

MARTINI: Dr. Buyx, if you look at the situation, you can see the anti-vaccine crowd loudly protesting, saying that they really do not want a vaccine. From the perspective of medical ethics, are we doing something wrong? Can we somehow help out and say “Yes, a vaccine such as this can have these sorts of effects”?

BUYX: This is really an interesting question. I don’t believe we have done anything exceptionally wrong. We know that there are groups who are really against vaccines. These are however small groups. They are merely very loud. They have been around for quite a while. This is a debate that we have had for decades, most especially during the last two. Up till now they only made up two, three per cent of the population, and now they number around four or five percent. I don’t know the most recent figures. Perhaps the numbers have risen a bit, this is a very loud group, which means that we must communicate well. What is very interesting that is that we cannot get through to the most hard-line anti-vaxxers. There is good data showing that they are relatively unreachable. But around 20, 30% of the population have reservations or feel skeptical about vaccines. I believe these are the people Professor Greiner was talking about when he spoke of those who would rather wait and see. It is much easier to get through to them. It is of course  important to ensure that the loudest anti-vaxxers do not reach them as well as those who are offering vaccines. For this reason, it is, as I have already said, very, very important that we proceed properly from the start of vaccinations, and that we are very transparent about what exactly that vaccine is. How was it researched? We cannot afford to “cut corners”(4). For which people are the vaccines best suited? How will we go about with distribution? As transparently and openly as possible. And then from the perspective of medical ethics one could say…the German Ethics Council has written something about another vaccine, the measles vaccine, and is busy dealing with these issues of vaccination requirements and all of these other things. At the moment, this is a very controversial topic of discussion. I would say that we should stick to the facts. From the perspective of medical ethics, to do something willingly is preferable to being forced to do it. I am really optimistic that if this is all communicated well, the number of those willing to be vaccinated will over a certain period of time be very high. If people see this, that this is functioning, what an…advantage it’d be for one’s own life. I believe that this would be very attractive after the experiences we have had in this pandemic. I am also very confident that we will not have to think about requiring people to do so, which should always be the last resort. I really believe that if we take the time to do these things well, we can be very successful.

MARTINI: Dr. Eichler, you wish to add something?

EICHLER: Yes, I have to agree. I cannot say anything to the most hardline anti-vaxxers. I would rather not speak about them. But I would like to return to Professor Greiner’s penguin. This penguin mentality isn’t stupid at all. What if there really is a predator in the water? Then we must really do something. And I have previously missed that in the discussion. When on Day Zero we release a vaccine, we will have to think about how to distribute them. Who gets them first and so on. That is something. We must pay attention to what is happening to certain patients (who receive the vaccine). This means that the research doesn’t end the day the vaccine is released. That is a point that we might not be talking about as much as we should be in public debate. In other words, we will be following up on those who will have been vaccinated. To demonstrate safety, as well as long-term safety. What will happen after a year, two years and so on, in order to document their effectivity in clinical practice. We will not be satisfied knowing that the right decision was made. I believe the analogy of the penguins is very appropriate for the situation—we will not stop at knowing the right decision was made, but we will also convince the other penguins to jump into the water. Here, the elements of further observation, of further communication about the benefits and risks will be very important in convincing the rest of the penugins to jump in.

MARTINI: That’s a nice image. I would like to present another scenario to you. What would happen if we are not able to develop a vaccine? I believe you have somewhat ruled this scenario out. But, Dr. Addo, how would you imagine a life without a vaccine and yet with the virus?

ADDO: I have said that a vaccine is a step in the right direction. We are eight months into the pandemic and don’t yet have a vaccine. And yet we still are managing it—of course, under a lot of restrictions and with a lot of economic and social losses. However, we have beaten other pandemics without a vaccine, albeit ones that weren’t of a similar magnitude or that occurred within our lifetimes. We must however continue research into medication. We have seen the virus burn through the world, if I may put it that way, and one day it’ll go out. And someday, there will be a sort of immunity. And we will live with this virus for a certain period of time, perhaps with the vaccine. How the “new normal” looks—we all probably don’t know. I believe however that we are all optimistic because, looking at the data, there hopefully will be a working vaccine. Even if there isn’t one, we will somehow find our way through, if by other measures. And we must move forward through these different paths.

MARTINI: Dr. Eichler, you have said that there probably will be a vaccine. However, can you imagine a different scenario: one without a vaccine?

EICHLER: Of course this is a plausible scenario. However, we must ask…we are thinking of possibilities, not in terms of yes or no. The probability of us being without a vaccine in the next three, four years, is probably low. So I can afford to be optimistic. We will not have a perfect vaccine. The protective effect might not be 100%. We have so many different types of vaccines. Not all vaccines function on the same principle, but think, for instance, about the classes of an old medicine, the statins. If the first class didn’t help you, then the second and third probably wouldn’t either. We have so many different applications, modes of function, theories—so many that I believe that the probability that absolutely none of them work (considering the fact that now we know and have characterized the virus well) to be very low. Your question is (to reiterate: this is very unlikely), can we live without a vaccine? We will then have to live without a vaccine. European society has lived for centuries with an even worse virus, the poxvirus. It was a horrible virus, a blight on society for hundreds of years. Life went on however and the poxvirus was eliminated with an effective vaccine.

MARTINI: Professor Greiner, from your point of view, would it not be an economic catastrophe if all the pharmacological companies which have poured so much money into vaccine research end up without a vaccine?

GREINER: Yes, but not so much for the pharma companies, who will be able to manage, but for us as a society. Just as Dr. Eichler said, we must continue to live. And I believe that these economic structures will be very adaptable. This will come at a high price though. This means changes to the economy, more digital business, less stationary businesses. Production methods must be changed, whether in the short- or long-term, and this has, thank God, happened in slaughterhouses and other areas. Certain things may not be profitable anymore. Others will be very profitable—you can see this in the booming business of video conferencing systems. There would then be a phase, if in two or three years we see that there probably will be no vaccine, in which things would really come to a head. Not because of an extremely acute pandemic, but rather because all these structures present at the moment must be drastically altered. And this will lead to a lot of pressure to adapt, because countries will have even more work to do to grapple with even more special measures. So I wouldn’t worry about the pharmacological industry. If everything fails, the economy will find some way to generate money again. It is very adaptable. But we as a society, we will have to scrape by. But we’ll get through.

MARTINI: Dr. Buyx, as a society we will have to scrape by. Will society be able to do that? At the moment, the solution seems to be the vaccine. Can our system, our social system, perhaps break apart in the end? Or what do you believe will happen if we don’t find a vaccine?

BUYX: Certainly not, it won’t break apart. We are more resistant than that. But I believe, as Dr. Eichler has said, these different adaptations will of course be very necessary. I am as optimistic as ever and I’m glad that the other experts here today can look as optimistically at the prospect of a vaccine. But we have…we won’t stop thinking, so to say, about other measures, until there is positive news about vaccine development. We’re also thinking about how to find out how to connect infection rates to the rates of illness (how many people actually get sick) and then to connect those to the number who get seriously sick. How can we better and more quickly differentiate between those who show no symptoms throughout the duration of their illness and those who are severely ill? This is an important difference and we have learned much in this regard. The other thing we are starting to understand is: when do people become infectious? For one, we know if someone is infected. But we are learning more. Dr. Christian Drosten has published, in his plan for the summer, information about where you can draw the lines regarding infection. These are all things that we will learn more about. We know in the meantime much more about masks. We know much more about aerosols and so on and so forth. If there is no vaccine, I believe, that during the years that we will need—Dr. Addo has already said that hopefully this will come to an end eventually—for this period of time, we as a society will find a way to live. This is certainly not to be taken lightly and we will all be very happy when a vaccine is found. But this is no guarantee. And so many researchers and institutions are working on other things. We’ll hope either way that things go well with the vaccine.

MARTINI: I agree with this optimism and to conclude, I’ll ask this: Dr. Addo, in your opinion, what should a vaccine do, medically, if we find one?

ADDO: Medically, it must protect people from infection. It must have as few side effects as possible. The fewer doses are needed, the better. This is, I believe, the most important thing: it should be available throughout the world for those who need it. That would be my wish about the vaccine or the vaccines. And it must…I hope we will have vaccines that can reach different demographics, for instance vaccines for the elderly, as immunocompetent.

MARTINI: Dr. Eichler, in your opinion, what should a vaccine do according to the EMA? What should it be capable of?

EICHLER: It must be effective, in other words, it should have a real protective effect against the virus. It doesn’t have to be 100% effective, and I would like to take the time to move away from this all-or-nothing mentality. It must be effective enough, though. And what is big enough? This brings me to my second point. The vaccine must be safe and tolerable. Tolerable, meaning that when I take the vaccine, there won’t be extremely unpleasant side effects. Everyone can tolerate erythema. Most will be able to tolerate a mild, transient high temperature, but severe side effects would be problematic. And concerning safety, one can distinguish between tolerability and safety if they want. A vaccine should not cause severe side effects. This is what effectiveness and safety mean. And the third, which is a concern that may lie somewhat in the background—it should be able to be produced reliably. That means that the same quality should be present between authorities and between producers.

MARTINI: Professor Greiner, from a medico-economic perspective, what should this vaccine be capable of?

GREINER: My wish list is comprised of three things above all. The first is of course high effectiveness. High effectiveness always means a good cost-to-effect ratio. It almost doesn’t matter how much money it costs. Such a vaccine would be able to limit the damage caused by the pandemic. The second thing I wish for is more potential vaccines, most of all from an economic perspective, so we don’t have to rely only one or two candidates. This would be nice. If we have a range of possible vaccines and can promote discussion between the different suppliers, this would be, from the perspective of quality improvement, very welcome. And the third is that I hope that the vaccine is produced by a company that can produce it quickly and in great numbers. There are many different production processes. If it is an inactive vaccine(5). With inactivated vaccines longer production techniques are needed, the requirements are higher, production is more vulnerable to damage, and so on, or so I have heard. Hopefully there will be a vaccine that can be moved from the production site relatively easily and that can be produced in greater numbers if needed. I believe these are the main points from an economic perspective.

MARTINI: Dr. Buyx, from a medical ethics perspective, what should the vaccine be capable of?

BUYX: I can only repeat what has already been said. I’ll make this quick. To be effective at protecting, to be safe and tolerable, to work in the long term and to be available to as many people as possible. And more things, too. This is, so to say, a “concerto of wishes.” But from an ethical perspective, it’d be great if we could set prices at a socially acceptable range, perhaps even at the price it cost to produce, no more. And now two specific points, namely, that we find a good model to justly distribute the vaccines and that we can communicate well about this.
MARTINI: All I can say is thank you very much for speaking here with us.

ADDO: Thank you very much as well.

EICHLER: You’re welcome.

GREINER: No problem.

BUYX: Our pleasure.

MARTINI: And that was our Coronavirus Update. A special edition during the winter break. This podcast can be found in the Audio Library and at ndr.de/coronaupdate. Of course, there will be a transcript (https://www.ndr.de/nachrichten/info/coronaskript218.pdf, in German). Please enjoy reading it. We would like to thank the editorial support of Daniela Remus, Charlotte Horn, Jenny von Gagern and Marc-Oliver Rehrmann. And of course technical help from Christian Beseke. My name is Anja Martini and thank you for listening, until next time. Greetings from my colleague Korinna Henning. You know her from the conversations with Dr. Drosten. Our science editors don’t just deal with the topic of the coronavirus, but with many others, too.

-----NOTES----
1.	The name “AHA rules” is an acronym for those three measures (in German: Abstand halten, Hygiene beachten, Alltagsmasken tragen).
2.	Originally in English
3.	Originally in English
4.	Originally in English
5.	A vaccine made up of parts of a pathogen as opposed to an attenuated vaccine, which contains whole pathogens.